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The effect of synbiotic supplementation on oxidative stress indicators and nutritional status in professional futsal athletes

Protocol summary

Study aim
To assess the effect of a synbiotic supplement on oxidative stress indicators and nutritional status in professional futsal athletes. Comparing the effects of synbiotic vs. placebo on oxidative stress indicators (MDA, TAS, TOS, SOD). Comparing the effects of synbiotic vs. placebo on nutritional status (food intake, macronutrients, anthropometric indicators, body composition).
Design
Randomized, double-blind, placebo-controlled clinical trial on 30 athletes
Settings and conduct
Setting: Futsal hall, Jeeroft Football Association. Time Frame: Year 1403 (Iranian calendar). Ethical Approval: Obtained from Jeeroft University of Medical Sciences Ethics Committee. Registered with the Iranian Registry of Clinical Trials (IRCT). Participants: 30 male futsal players from the second division in Jeeroft. Sampling Method: Convenience sampling initially, followed by random block assignment (1:1 ratio). Randomization sequence managed by a non-involved individual. Blinding: Double-blind design; all participants, administrators, and data collectors are unaware of the treatment allocations.
Participants/Inclusion and exclusion criteria
Inclusion Criteria Male, aged 18-35. 1+ year futsal experience. Practice 2-3 times a week. Permanent team member. No autoimmune/metabolic/infectious diseases. Consent to participate. Exclusion Criteria Probiotic intolerance. Recent use of certain medications or supplements. Specific muscle diseases or injuries. Absence from >6 sessions or non-compliance. Tobacco, drug, or alcohol use.
Intervention groups
Intervention Group: Receives a synbiotic supplement daily (one capsule per day) for 8 weeks. Control Group: Receives a placebo daily (one capsule containing starch) for 8 weeks.
Main outcome variables
Oxidative Stress Markers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100123003140N24
Registration date: 2024-08-21, 1403/05/31
Registration timing: registered_while_recruiting

Last update: 2024-08-21, 1403/05/31
Update count: 0
Registration date
2024-08-21, 1403/05/31
Registrant information
Name
Bahram Pourghassem Gargari
Name of organization / entity
Health and Nutrition Faculty, Tabriz University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1435 7580
Email address
pourghassemb@tbzmed.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-08-16, 1403/05/26
Expected recruitment end date
2025-07-28, 1404/05/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of synbiotic supplementation on oxidative stress indicators and nutritional status in professional futsal athletes
Public title
The effect of synbiotics on oxidative stress indicators
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male gender People with at least 1 year of futsal sports experience Having at least 2-3 futsal practices per week Being a permanent member of the team and registering one's profile in the national league Not having specific diseases such as autoimmune diseases, metabolic disorders, infectious and inflammatory diseases, etc. Declare agreement to participate in the plan and complete the plan's informed consent Not taking other sports supplements
Exclusion criteria:
Having a specific muscle injury or disease before the start of the study Intolerance and sensitivity to probiotics and similar products Taking antibiotics, anti-inflammatory drugs, painkillers, acute and chronic disease, drugs for acute and chronic disease or other drugs in the last month Using drugs that affect lipid metabolism, such as cholesterol-lowering drugs, estrogen, progesterone, diuretics, niacin, tricyclic antidepressants, antiepileptic drugs (phenytoin, valproic acid, carbamazepine, and phenobarbital) and taking drugs that affect appetite and body weight. , drug for controlling blood sugar in diabetic patients and insulin therapy Smoking or drinking alcohol Improper use of supplements or any non-cooperation Absence and non-attendance in competitions and training sessions
Age
From 18 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
In this double-blind study, neither the researcher nor the participants will know whether each person will be in the intervention group or the control group. For blinding, synbiotic and placebo pills will be similar in appearance, packaging and labeling. Packaging and coding of the capsules will be done by the manufacturer.
Blinding (investigator's opinion)
Double blinded
Blinding description
Subjects will be grouped into two groups of intervention (receiver of synbiotic supplement) and control (receiver of placebo) by random block method and 1:1 allocation ratio. In order to conceal the allocation (Concealment Allocation), the sequence of allocation is specified by a person not involved in the study and in a blinded manner using Randomizer (https://www.randomizer.org/) and drugs and placebo are also in completely identical boxes. which were numbered consecutively from 1 to 30, will be placed. For the intervention group, Familact synbiotic supplement capsules will be given and for the control group, a placebo containing starch will be given daily for three months. Therefore, the participants, the person allocating the participants in the groups, the person delivering the supplement and placebo and the data collector, will be blinded and unaware of the type of capsules received by each participant. Each box will contain 30 capsules, 1 package in the first visit and another package with the same code every month for 3 months, after delivery of the check list of drug consumption and previous empty boxes will be delivered. Synbiotic product (probiotic + prebiotic) Femilact with 30 capsules, gluten-free, containing a mixture of probiotic strains: Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium lactis, Streptococcus thermophilus, Fructooligosaccharides (FOS) in a combined amount of 109 CFU and Fructooligosaccharides (FOS) will be used (as a prebiotic). became. The placebo in the form of a capsule containing starch and the contents of ineffective substances are completely similar to the synbiotic capsule in terms of color and weight. It is necessary to mention that the safety of this supplement has been examined and confirmed in previous studies. Envelopes with questionnaires will be given to the athletes and they will be told to continue taking one pill daily.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee and Vice President of Research and Technology of Jiroft University of Medical Scien
Street address
Central Headquarters of Jiroft University of Medical Sciences and Health Services, Shohada Ashayer Building, Enghelab Square, Jitoft
City
Jiroft
Province
Kerman
Postal code
7861634200
Approval date
2024-07-17, 1403/04/27
Ethics committee reference number
IR.JMU.REC.1403.027

Health conditions studied

1

Description of health condition studied
Oxidative Stress: This condition involves an imbalance between free radicals and antioxidants, leading to cellular damage. our study investigates how synbiotic supplementation affects oxidative stress levels in futsal players.Nutritional Status: Refers to the health condition determined by diet and nutrient intake. our study examines the impact of synbiotic supplements on the nutritional status of professional futsal players.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Measurement of oxidative stress levels in professional futsal players, assessed through biomarkers such as malondialdehyde (MDA) and total antioxidant capacity (TAC).
Timepoint
Measurement will be conducted at baseline, and then at the end of the intervention.
Method of measurement
Oxidative stress will be measured using blood samples analyzed for MDA and TAC levels via spectrophotometry.

Secondary outcomes

1

Description
Assessment of nutritional status and nutritional intake
Timepoint
Measurement will be conducted at baseline, and then at the end of the intervention.
Method of measurement
Nutritional status will be assessed using 3 day dietary recall questionnaire.

Intervention groups

1

Description
Intervention group: Football players in this group will receive a synbiotic supplement daily (one capsule per day) for 8 weeks.
Category
Treatment - Drugs

2

Description
Control group: Participants in this group will receive a placebo, which is a capsule containing starch, also administered daily for 8 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Jiroft City Football Board
Full name of responsible person
Mahdi Azami
Street address
Sports and Youth Department of Jiroft city, Zahmatkeshan Stadium, Imam Khomeini Blvd., Jiroft, Iran.
City
Jitoft
Province
Kerman
Postal code
7861611111
Phone
+98 34 4335 3292
Email
Jiroftfootball@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Mohammad Ali Hasanzadeh
Street address
Central Headquarters of Jiroft University of Medical Sciences and Health Services, Shohada Ashayer Building, Enghelab Square, Jiroft
City
Jitoft
Province
Kerman
Postal code
7861634200
Phone
+98 34 4331 9085
Email
smim8035@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Jiroft University of Medical Sciences, Jiroft, Iran
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Pourghassem Gargari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar Neishaboori St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1435 7580
Fax
+98 41 1334 0634
Email
pourghassemb@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Jeeroft University of Medical Sciences
Full name of responsible person
Mohammad Ali Hasanzadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Central Headquarters of Jiroft University of Medical Sciences and Health Services, Shohada Ashayer Building, Enghelab Square, Jiroft
City
Jiroft
Province
Kerman
Postal code
7861634200
Phone
+98 34 4331 9085
Fax
Email
smim8035@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bahram Pourghassem Gargari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Attar Neishaboori St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 1435 7580
Fax
+98 41 1334 0634
Email
pourghassemb@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
all results
When the data will become available and for how long
En After completing the study and publishing the articles
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
With the permission of the researcher and sponsor of the project
From where data/document is obtainable
Project researchers
What processes are involved for a request to access data/document
email or phone call
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